MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-18 for OLYMPUS 4060 * CUT 4060 manufactured by Olympus America Inc..
[376114]
Consider making the fly wheel/advance wheel interchangable for left handed personnel
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 567525 |
| MDR Report Key | 567525 |
| Date Received | 2005-01-18 |
| Date of Report | 2005-01-13 |
| Date of Event | 2005-01-01 |
| Report Date | 2005-01-13 |
| Date Reported to FDA | 2005-01-18 |
| Date Added to Maude | 2005-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS 4060 |
| Generic Name | MICROTOME |
| Product Code | IDP |
| Date Received | 2005-01-18 |
| Model Number | * |
| Catalog Number | CUT 4060 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 557353 |
| Manufacturer | OLYMPUS AMERICA INC. |
| Manufacturer Address | SCIENTIFIC EQUIPMENT GROUP 2 CORPORATION CENTER DRIVE MELVILLE NY 11747 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-18 |